BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMUFLEX DISPOSBLES

    MDR report key: 2972363 · Received February 21, 2013

    Report

    Report Number
    1722028-2013-00958
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 24, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    KSR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    .INVESTIGATION: THE DISPOSABLE SETS WERE NOT RETURNED FOR INVESTIGATION. RESERVE SAMPLES FOR THIS LOT WERE VISUALLY EXAMINED, AND THE SOLUTION VOLUME AND SOLUTION COMPOSITION WERE TESTED,WITH NO ABNORMALITIES NOTED. HEMOLYSIS TESTING WAS PERFORMED ON THE CATIONIZED AND SUPER-CATIONIZATED MEMBRANES FROM ATYPICAL HEMOLYZED LOT, WITH HEMOLYSIS FOUND. THE MANUFACTURING AND TESTING RECORDS WERE REVIEWED WITH NO ISSUES NOTED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE CATIONIZATION LEVELS OF THE FILTERS IS CAUSING THE HEMOLYSIS. HEMOLYSIS CAN ALSO BE CAUSED BY THE FOLLOWING:-CHARACTERISTICS OF BLOOD, E.G. RED BLOOD CELL FRAGILITY-BACTERIAL CONTAMINATION-EXCESSIVE COOLING-FILTER CLOGGING CORRECTIVE ACTION: AN UPPER LIMIT OF THE AVERAGE CATIONIZATION LEVEL HAS BEEN ESTABLISHED AND IMPLEMENTED IN LOTS NOW BEING MANUFACTURED.

    Additional Manufacturer Narrative · 1

    (B)(4) INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE IS DISCARDING APPROXIMATELY 20-30% OF THE PLASMA BEING DRAWN AT HIS BLOOD CENTER DUE TO A RED TINGE THE CUSTOMER IS DESCRIBING AS HEMOLYSIS. THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THE WHOLE BLOOD PROCESSING FOR PLASMA UNITS, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO A DEVICE MALFUNCTION THAT HAS THE POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75711 IMUFLEX DISPOSBLES IMUFLEX WB-RP BLOOD BAG SYSTEM KSR TERUMO BCT 120702KK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other